Zanubrutinib in the Treatment of Relapsed/Refractory wAIHA

Launched by CHEN MIAO · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called zanubrutinib in patients with a condition known as warm autoimmune hemolytic anemia (wAIHA). This condition occurs when the body's immune system mistakenly destroys its own red blood cells, leading to anemia. The trial aims to find out if zanubrutinib can help those who have not responded to standard treatments, particularly glucocorticoids, or who have experienced relapses after treatment.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of wAIHA or Evans syndrome. It's important that you've not had a good response to glucocorticoids and that certain health criteria are met, such as having stable liver and kidney function. If you join the trial, you can expect to receive zanubrutinib and be monitored closely for its effects and any potential side effects. This study is currently recruiting participants and aims to explore a new treatment option for those struggling with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years.
• • 2. Confirmed diagnosis of wAIHA or Evans syndrome, primary or secondary to connective tissue disease. If it is secondary, there are no other treatment indications for systemic involvement of primary connective tissue disease.
• • 3. No response or relapse after glucocorticoid treatment.
• • 4. Baseline liver and kidney function (ALT, AST, Cr) is less than 2 times the normal range.
• • 5. Consent to sign the informed consent form.
• Exclusion Criteria:
• • 1. Other important organ involvement in connective tissue disease.
• • 2. Uncontrolled infection or bleeding with standard treatment.
• • 3. Active HIV, HCV or HBV infection uncontrolled with standard treatment.
• • 4. Concurrent uncontrolled advanced malignant tumors or lymphoma.
• • 5. The subject is receiving any of the following drugs and has not met the following conditions of stable drug treatment duration at a fixed dose during screening: corticosteroids for at least 4 weeks; iron, vitamin B12 or folic acid for at least 4 weeks;
• • 6. Liver cirrhosis or portal hypertension.
• • 7. Pregnant or lactating women.
• • 8. Participation in other clinical trials within the last 3 months.